This study explores the efficacy and safety of fruquintinib combined with irinotecan in the second-line treatment of patients with advanced gastric cancer, aiming to bring more second-line treatment options for patients with advanced gastric cancer.
This study was a single-arm, open-label, single-center phase II study. A total of 47 patients with advanced gastric cancer who had previously failed standard first-line therapy were recruited to receive combined treatment with fruquintinib and irinotecan. The patients' progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety were evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
4 mg PO, QD (3 weeks on, 1 week off)
participants will receive irinotecan, 100 mg/m2, intravenous drip, day1 and day 14 of every 4 weeks
Progression-free survival (PFS)
PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Objective remission rate (ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain amount and kept for a certain time, including cases of complete remission and partial remission.
Time frame: up to 12 months
Disease control rate (DCR)
The percentage of patients whose tumors shrink or stabilize for a certain amount of time. DCR is the sum of complete, partial response and stable rate, that is, DCR=CR+PR+SD.
Time frame: up to 12 months
Overall survival(OS)
OS was defined as the time from the date of randomization to the date of death due to any cause. For subjects who were alive or lost to follow-up by the data analysis cut-off date, survival was censored at the subject's last known survival time.
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
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